Kornimate/medical-research-clean huggingface dataset:
high frame rate ultrasound in heart disease assessment

Conditions: Coronary Artery Disease

Summary: the study will compare standard ultrasound images to high frame rate ultrasound images in patients with heart disease or with a low risk of heart disease to see if a higher frame rate of ultrasound adds to the information obtained from standard ultrasound.

following informed consent, patients recruited for the study will have an iv cannula inserted and will undergo imaging using 2 ultrasound systems. standard clinical system (philips ie33) will be used for 2d and ce imaging, followed by imaging using the verasonics vantagetm research system (verasonics inc., redmond, wa), using both conventional 2d and hfr modes. baseline unenhanced 2d and doppler images would initially be acquired using philips ie33 system and verasonics vatangetm unenhanced conventional 2d and hfr mode . ultrasound contrast agent (sonovue) will be then injected via the intravenous (iv) cannula and 3 sets rest contrast images will be acquired - using the phillips ie33, verasonics and verasonics vantagetm platform (conventional ce and hfr ce). both systems will be optimised separately on each patient before and during infusion of contrast agent. when the optimal imaging and destruction parameters are set, there are not modified along the acquisition. this is followed by dipyridamole infusion and the scans being repeated during stress - 3 sets contrast images will be acquired - using the philips ie33 and verasonics vantagetm platform (conventional ce and hfr ce).

Eligibility criteria:
inclusion criteria either * ability to give informed consent * age ≥18years and * confirmed inducible wall motion / perfusion abnormality on previous stress echocardiogram * known coronary artery disease - defined by presence of flow-limiting coronary stenosis(\>70% diameter stenosis) on coronary angiography. or • patient who has been assessed as at low risk of having coronary heart disease exclusion criteria: * inability to undertake pharmacological stress, ie previously known intolerance to dipyridamole; * moderate or severe aortic or mitral regurgitation or severe mitral stenosis; * significant pulmonary disease like severe copd or pulmonary fibrosis; * atrial fibrillation; * inability to provide informed consent; * pregnancy and lactation; * known allergy to sonovue * patients with second and third degree heart block, unless they have a pacemaker fitted * systolic bp \< 90 * known myasthenia gravis * bronchial asthma

Keywords: echocardiography
a study of jnj-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is see how effective is jnj-77242113 in participants with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to the first administration of study intervention * total body surface area (bsa) greater than or equal to (\>=)10 percent (%) at screening and baseline * total psoriasis area and severity index (pasi) \>=12 at screening and baseline * total investigator global assessment (iga) \>=3 at screening and baseline * candidate for phototherapy or systemic treatment for plaque psoriasis * a female participant of childbearing potential must have a negative highly sensitive serum pregnancy test beta-human chorionic gonadotropin (beta-hcg) at screening and a negative urine pregnancy test at week 0 prior to administration of study intervention exclusion criteria: * nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular) * current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * known allergies, hypersensitivity, or intolerance to jnj-77242113 or its excipients * major surgical procedures, (for example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from a surgical procedure or has a surgical procedure planned during the time the participant is expected to participate in the study
3d ultrasound to assess in recurrent miscarriage

Conditions: Recurrent Miscarriage

Summary: this observational study aims to compare the prevalence of acquired abnormalities of the uterus (fibroids, polyps, intrauterine adhesions, adenomyosis) in women who have recurrent miscarriages with the fertile population.

high-quality studies including several meta-analyses have proven the association between congenital uterine anomalies and recurrent miscarriages. nevertheless, there are limited studies evaluating the impact of acquired uterine anomalies on recurrent miscarriages. this prospective observational study will aim to compare the prevalence of acquired uterine anomalies between the study group and the control group. the secondary aim will be to compare the endometrial morphological features like endometrial volume, endometrial and sub-endometrial vascularity between the two groups

Eligibility criteria:
inclusion criteria: 1. women between the age group of 18-40 years 2. women who have had 2 or more pregnancy losses before 24 weeks of gestation - study group. 3. women who can provide documented informed consent 4. women with proven fertility with at least one child - control group exclusion criteria: 1. women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the control group.

Keywords: fibroids polyps adhesions adenomyosis endometrial blood flow
continuous wireless monitoring of vital signs and automated alerts of postsurgical patient deterioration.

Conditions: Complication,Postoperative

Summary: the primary aim of the current study is to assess the effect of continuous wireless vital sign monitoring with generation of real-time alerts, compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards after major surgery. we hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.


Eligibility criteria:
inclusion criteria: * admission for acute or elective major abdominal (laparotomy/laparoscopy), major orthopedic, major urologic, or arterial vascular surgery. * estimated duration of surgery ≥2 hours and at least two expected overnight stays. * randomization and commencement of continuous wireless monitoring possible within 24 hours postoperatively exclusion criteria: * patient expected not to cooperate with study procedures. * allergy to plaster or silicone. * impaired cognitive function (in uncertain cases assessed by a mini mental state examination\] score \< 24) * patients admitted for palliative care only (i.e. no active treatment). * planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit). * patients previously enrolled in the medical ward rct. * patients with a pacemaker or implantable cardioverter defibrillator (icd) device. * inability to give informed consent.

Keywords: wireless monitoring vital signs physiologic deterioration
evaluation of reporting of cardio-vascular adverse events with antineoplastic and immunomodulating agents (eroca)

Conditions: Cardiac Disease; Cancer

Summary: antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse reactions. this study investigates reports of cardio-vascular toxicities for treatment including anatomical therapeutic chemical (atc) classification l (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the world health organization's (who) global database of individual safety case reports (vigibase).

antineoplastic therapies are responsible of a wide range of cardio-vascular side effects.the investigators use vigibase, the world health organization (who) database of individual safety case reports, to identify cases of cardiovascular adverse drug reactions following treatment with antineoplastic and immunomodulating agents

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case reports to 30/04/2018 * adverse events reported were including the meddra terms: cardiac and vascular investigations (excl enzyme tests) (hlgt), vascular disorders (soc), skeletal and cardiac muscle analyses (hlt), sudden death (pt), sudden cardiac death (pt), cardiac disorders (soc), cardiac arrhythmias (hlgt), cardiac disorder signs and symptoms (hlgt), cardiac neoplasms (hlgt), cardiac valve disorders (hlgt), congenital cardiac disorders (hlgt), coronary artery disorders (hlgt), endocardial disorders (hlgt), heart failures (hlgt), myocardial disorders (hlgt), pericardial disorders (hlgt) * patients treated with antineoplastic and immunomodulating agents included in the atc l. exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: cardiotoxicity antineoplastic and immunomodulating agents
pulp revascularization versus mta apexification

Conditions: Necrotic Pulp

Summary: this study compared the efficiency of pulp revascularization and mta apexification in the treatment of patients with necrotic immature anterior teeth.

the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and mta apexification. at the first visit, all teeth were accessed and irrigated with naocl then a tap was applied as intra-appointment intracanal medication. at the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the mta in the orifice in the regeneration group. while in the apexification group, the mta was packed apically and all teeth were finally restored with resin composite restorations. the patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.

Eligibility criteria:
inclusion criteria: * medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention. exclusion criteria: * history of allergy to any of the antibiotics in the tri-mix used in the study * patients with systemic diseases e.g. diabetes mellitus, bleeding disorders,... * psychological disturbance * external / internal root resorption or cystic lesion.

Keywords: regeneration, mta apexification and tap revascularization
diamel in the treatment of metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to assess the efficacy of diamel administration in the treatment of metabolic syndrome. the duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.


Eligibility criteria:
inclusion criteria: * metabolic syndrome diagnosis according to who definition, with or without glucose intolerance. * signed informed consent exclusion criteria: * type 1 diabetes * type 2 diabetes treated with oral hypoglycemic drugs and/or insulin * other diseases associated with insulin resistance (eg. acromegalia, endogenous hypercortisolism, etc) * neuropathies or hepatic conditions diagnosed biochemically or by clinical exam. * mild or severe heart conditions (eg. heart failure, ischemic cardiopathy) * sepsis or any other condition that could potentially interfere with treatment * any other treatment that could potentially interfere with treatment * pregnancy

Keywords: dietary supplement diamel metabolic syndrome
selinexor treatment of refractory myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (sd) dosed twice weekly in four-week cycles, in patients with penta-refractory mm (parts 1 and 2) or quad refractory mm (part 1 only).

this is a phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (sd), both dosed twice weekly in each four-week cycle, in patients with mm previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (imid), a proteasome inhibitor (pi), and daratumumab. this study consists of two parts: * part 1 enrolled patients with both quad-refractory mm and penta-refractory mm. * part 2 will enroll patients with penta-refractory mm only.

Eligibility criteria:
inclusion criteria: measurable mm based on modified imwg guidelines. defined by at least one of the following: 1. serum m-protein ≥ 0.5 g/dl by serum electrophoresis (spep) or for iga myeloma, by quantitative iga 2. urinary m-protein excretion ≥ 200 mg/24 hours 3. free light chain (flc) ≥ 100 mg/l, provided that the flc ratio is abnormal 4. if serum protein electrophoresis is felt to be unreliable for routine m-protein measurement, then quantitative ig levels by nephelometry or turbidimetry are acceptable * must have previously received ≥ 3 anti-mm regimens including: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a glucocorticoid. there is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met. * mm refractory to previous treatment with one or more glucocorticoids, parenteral pi (i.e., bortezomib and/or carfilzomib), imid (i.e., lenalidomide and/or pomalidomide), and the anti-cd38 mab, daratumumab. refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy. exclusion criteria: * active smoldering mm. * active plasma cell leukemia. * documented systemic amyloid light chain amyloidosis. * active cns mm.

Keywords: multiple myeloma karyopharm kpt-330 selinexor refractory bortezomib carfilzomib lenalidomide pomalidomide dexamethasone storm daratumumab
pharmacokinetics of ledipasvir/sofosbuvir in hepatitis c virus-infected children with hematological malignancy

Conditions: Hepatitis C, Chronic; Hematologic Malignancy

Summary: this is a prospective, controlled, open-label, pharmacokinetic study. this study aims at studying the pk of ledipasvir, sofosbuvir, and gs-331007 metabolite in hcv infected children with hematological malignancy. in this study, patients in both treatment groups will receive 12 weeks of treatment with a ﬁxed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (ldv/sof) orally, once daily with food.

in this study, patients in both treatment groups will receive 12 weeks of treatment with a ﬁxed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (ldv/sof) orally, once daily with food, as prescribed by the attending physician. twelve eligible hcv-infected patients with hematological malignancy and 12 matching hcv control patients without haematological malignancy or co-morbidities will be enrolled in the study. at baseline, careful history of the recruited patients including demographic characteristics (age, height, weight, and gender), comorbidities, medication history, familial history, social history, blood transfusion history, time on maintenance chemotherapy, and baseline laboratory tests will be documented. the baseline laboratory tests will include renal function tests (serum creatinine), liver function tests (bilirubin, albumin, ast, and alt), international normalized ratio (inr), alpha fetoprotein (afp), complete blood count (cbc), degree of liver fibrosis by fibroscan, and viral load by pcr. followup will be done for all participants at baseline, after 12 weeks of treatment, and after 12 weeks from the end of treatment. a forth visit will be done after 10 days of treatment for the evaluation of the steady state pk parameters of ldv\\sof in those patients.

Eligibility criteria:
inclusion criteria: * children (6 to \< 12 years of age and/or weighing 17.5 to \< 35 kg). * chronic hcv genotype 4 infection for at least 6 months without cirrhosis (confirmed by fibroscan). * naïve patients to previous anti-hcv treatment. * diagnosed with hematological malignancy and on maintenance chemotherapy. exclusion criteria: * known hypersensitivity to any of the study medications. * ongoing treatment with any interacting medications like carbamazepine, fosphenytoin, phenytoin, oxcarbazepine, phenobarbital, and rifampin. * history of any comorbid illness that may interfere with the pharmacokinetics of the study drugs or prohibit the compliance with the study protocol such as; 1. decompensated liver disease as shown by the presence of ascites, encephalopathy, or a history of variceal hemorrhage. 2. the ongoing treatment of other types of cancer or blood disorders. 3. co-infection with human immunodeficiency virus (hiv), or hepatitis b virus. 4. renal dysfunction. 5. active infection that is currently producing symptoms.

Keywords: hepatitis c virus pharmacokinetic modeling pharmacokinetics pediatrics leukemia ledipasvir sofosbuvir antiviral drugs
quality of life and psychology of donors after hepatectomy

Conditions: Quality of Life

Summary: liver donation by a living donor is major surgery and has a profound effect on health-related quality of life and psychology. this study aims at evaluating those aspects of a donor for a period of five years after surgery.

live donor liver transplantation (ldlt) has established itself as a treatment for end-stage liver disease but donor safety remains a major issue. it is the responsibility of the transplant team to restore donor's health, not only physical, but also mental, social and environmental. there is scarcity of long term longitudinal data on donor quality of life. most of the studies are cross sectional which describe the quality of life at certain time point and do not take into account of changes that might occur over a period. it is more relevant in this scenario, as two persons from a family undergo surgery at the same time, which has a profound effect on family dynamics, and restoration towards normalcy goes hand in hand with adaptation to a new lifestyle. another shortcoming of available literature is lack of uniform instruments which comprehensively measure the quality of life of live liver donors (llds). standardized health related quality of life (hrqol) instruments such as short form 36(sf 36) or world health organization quality of life brief (whoqol-bref) are not designed for llds. moreover, there are several symptoms which might interfere with daily activities such as incision site problems , dyspepsia to name a few, but are not distressing enough to be reflected on quality of life scores .the aim of current study was to observe the attitude of donors pre transplant, quality of life over a period, satisfaction with the donation process, their assessment of the health care team, satisfaction with the consent process, and change in pattern of symptoms and cosmesis after surgery.

Eligibility criteria:
inclusion criteriteria: - all patients undergoing donor hepatectomy from march 2012 to august 2013 exclusion criteria: - refusal to participate in study
memantine in the treatment of kleptomania

Conditions: Kleptomania

Summary: the goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.

the proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. the hypothesis to be tested is that memantine will be effective in reducing the urges to steal in patients with kleptomania. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria:
inclusion criteria: 1. men and women age 18-65 2. current km using the clinician-administered structured clinical interview for kleptomania (sci-k) 3. stealing behavior within 2 weeks prior to enrollment. exclusion criteria: 1. infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (km) 2. unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen 3. history of seizures 4. myocardial infarction within 6 months 5. current pregnancy or lactation, or inadequate contraception in women of childbearing potential 6. a need for medication other than memantine with possible psychotropic effects or unfavorable interactions 7. clinically significant suicidality 8. current axis i disorder determined by the structured clinical interview for the dsm (scid) and scid-compatible modules for impulse control disorders (grant et al., 2005), except for nicotine dependence 9. lifetime history of bipolar disorder type i or ii, dementia, schizophrenia, or any psychotic disorder determined by scid 10. current or recent (past 3 months) dsm-iv substance abuse or dependence 11. positive urine drug screen at screening 12. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline 13. previous treatment with memantine; and 14) treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.

Keywords: compulsive stealing compulsive shoplifting
ang-first trial (angiotensin ii as first-line vasopressor therapy in cardiac surgery)

Conditions: Hypotension After Cardiac Surgery

Summary: the purpose of this research is to evaluate the use of angiotensin ii in patients with low blood pressure post-surgery. your information will be collected for 28 days post the procedure and initiation of the study drug to assess for safety events and complications.


Eligibility criteria:
inclusion criteria: * 1. adult patients ≥ 18 years of age. 2. patients must have clinical features of vasodilation, as determined by a map \< 65 mmhg requiring any dose of vasopressors intra/post-operatively 3. patients must be adequately volume resuscitated in the opinion of the treating physician. exclusion criteria: -1. patients with active bleeding as the primary reason for hypotension and an anticipated need for transfusion of \> 4 units packed red blood cells within the next 48 hours. 2. history of atrial fibrillation 3. patients already on renal replacement therapy or creatinine of \> 4 mg/dl within 2 weeks of surgery